Oral Paclitaxel for the Treatment of Cancer
A Randomized Crossover Study to Determine the Bioequivalence of Three Consecutive Daily Doses of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel
Kinex Pharmaceuticals Inc
40 participants
Aug 26, 2015
Interventional
Conditions
Summary
Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. The purpose of this study is to measure the levels of paclitaxel in your blood at different times when given by intravenous (IV) drip (through a vein in your arm) compared to the levels of paclitaxel at different times in your blood when given by mouth (as Oraxol).
Eligibility
Inclusion Criteria2
- Eligible participants are cancer patients for whom treatment with IV paclitaxel at 80 mg/m2 has been recommended by their oncologist, either as monotherapy or in combination with other agents. They must have adequate hematologic status and liver and renal function at Screening/Baseline; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and life expectancy of at least 3 months.
- They must be willing to fast for 8 hours before and 4 hours after Oraxol administration; willing to abstain from alcohol consumption for 3 days before the first dose of study drug through the completion of protocol-specified PK sampling in Treatment Period 2; willing to refrain from caffeine consumption for 12 hours before each treatment period through the completion of protocol-specified PK sampling for that dose. Women must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or, if sexually active, must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for the duration of their participation in the study. Women of childbearing potential must agree to use contraception for 30 days after their last dose of study drug. Sexually active male participants must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
Exclusion Criteria1
- Study participants must not be currently taking a prohibited concomitant medication; have unresolved toxicity from prior chemotherapy; have received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer. Other exclusions are women of childbearing potential who are pregnant or breast feeding; uncontrolled intercurrent illness; major surgery to the upper gastrointestinal tract, or have a history of GI disease or other medical condition that, in the opinion of the Investigator may interfere with oral drug absorption; known history of allergy to paclitaxel; any other condition which the investigator believes would make a subject’s participation in the study not acceptable
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Interventions
Stage 1 is a cohort of up to 6 patients (Cohort 1), to confirm the dose of Oraxol when compared with IV paclitaxel. This is a randomised trial and therefore Oraxol may be administered in Treatment Period 1 or Treatment Period 2. Oraxol is administered over three days (i.e. Days 1, 2 and 3 of the applicable Treatment Period). The daily dose of Oraxol is one HM30181AK-US 15mg tablet administered one hour before oral paclitaxel 205mg/m2. Oraxol will be administered at the study site on each dosing day. Patients need to fast for 8 hours before and 4 hours after Oraxol administration. Dosing for Treatment Period 2 may start on the last day of PK sampling for Treatment Period 1, or may be delayed for up to 3 weeks, if needed, to allow the participant to recover to less than or equal to Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) or baseline toxicity from the prior study treatment or to allow the participants flexibility in scheduling inpatient treatment. An interim analysis of pharmacokinetic (PK) data from Cohort 1 will be conducted to determine if the administered regimen would appear likely to achieve BE (AUC0-inf), if tested in a greater number of participants in Stage 2. A decision will be made by consensus of the DSMB, Kinex, Zenith Technology, and the Principal Investigator as to whether a second cohort administered a different dose is required to complete Stage1 or whether the study can proceed to Stage 2 using the dose administered in Stage 1. An additional 18 to 42 evaluable participants will be enrolled into Stage 2 based on the Stage 1 results (AUC0-inf). The study design for Stage 2 is the same as for Stage 1.
Locations(6)
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ACTRN12615000894594